Three-dimensional (3D) printing technologies are based on successive material printing layer-by-layer and are considered suitable for the production of dosage forms customized for a patient’s needs. In this study, tablets of atomoxetine hydrochloride (ATH) have been successfully fabricated by a digital light processing (DLP) 3D printing technology. Initial materials were photoreactive suspensions, composed of poly(ethylene glycol) diacrylate 700 (PEGDA 700), poly(ethylene glycol) 400 (PEG 400), photoinitiator and suspended ATH. The amount of ATH was varied from 10.00 to 25.00% (w/w), and a range of doses from 12.21 to 40.07 mg has been achieved, indicating the possibility of personalized therapy. The rheological characteristics of all photoreactive suspensions were appropriate for the printing process, while the amount of the suspended particles in the photoreactive suspensions had an impact on the 3D printing process, as well as on mechanical and biopharmaceutical characteristics of tablets. Only the formulation with the highest content of ATH had significantly different tensile strength compared to other formulations. All tablets showed sustained drug release during at least the 8h. ATH crystals were observed with polarized light microscopy of photoreactive suspensions and the cross-sections of the tablets, while no interactions between ATH and polymers were detected by FT-IR spectroscopy.

Multiple emulsions are complex dispersion systems which have many potential applications in pharmaceutics, cosmetics and the food industry. In practice, however, significant problems may arise because of their thermodynamic instability. In this study, W/O/W multiple emulsion systems containing low concentration levels of lipophilic polymeric primary emulsifiers cetyl dimethicone copolyol and PEG-30 dipolyhydroxystearate were evaluated. The concentrations of the primary emulsifiers were set at 1.6 and 2.4 % w/w in the final emulsions. Rheological and droplet size analysis of the investigated samples showed that the type and concentration of the primary lipophilic polymeric emulsifier markedly affected the characteristics of the multiple emulsions. The multiple emulsion prepared with 2.4 % w/w PEG-30 dipolyhydroxystearate as the primary emulsifier exhibited the highest apparent viscosity, yield stress and elastic modulus values, as well as the smallest droplet size. Furthermore, these parameters remained relatively constant over the study period, confirming the high stability of the investigated sample. The results obtained indicate that the changes observed in the investigated samples over time could be attributed to the swelling/breakdown mechanism of the multiple droplets. Such changes could be adequately monitored by rheological and droplet size analysis.

Inkjet printing is novel approach in drug manufacturing that enables dispensing precise volumes of ink onto substrates. Optimal substrate properties including suitable mechanical characteristic are recognized as crucial to achieve desired dosage form performance upon administration. Identification of relevant quality attributes and their quantification is subject of intensive scientific research. The aim of this work was to explore applicability of different materials as printing substrates and explore contribution of the investigated substrate properties to its printability. Substrates were characterized with regards to uniformity, porosity, disintegration time, mechanical properties and drug dissolution. Experimentally obtained values were mathematically transformed and the obtained results were presented as relevant radar charts. It was shown that structurally different substrates may be employed for orodispersible films inkjet printing. Main disadvantage of single-polymer films was low drug load, and their printability was dependent on film flexibility and mechanical strength. Structured orodispersible film templates exhibited favorable mechanical properties and drug load capacity. Wafer edible sheets were characterized with high mechanical resistance and brittleness which somewhat diminished printability, but did not hinder high drug load. Obtained results provide insight into application of different materials as printing substrates and contribute to understanding of substrate properties which can affect printability.

Solid dispersions were prepared via a solvent evaporation method, employing ethanol (96%, v/v) as solvent, with three different polymers as carrier: povidone, copovidone, and poloxamer 407. Previously developed reversed-phase HPLC (RP-HPLC) methods were modified and used for the simultaneous determination of acetylsalicylic acid and clopidogrel bisulfate and after release from solid dispersions. Chromatography was carried out on a C-18 column, with a mobile phase of acetonitrile–methanol–phosphate buffer pH 3.0, UV detection at 240 nm, and a run time of 6 min. The method was validated according to International Conference of Harmonisation guidelines and validation included specificity, accuracy, precision, linearity, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method is specific for determination of acetylsalicylic acid and clopidogrel bisulfate. The linearity was provided in the concentration range 0.0275–0.1375 mg/mL for acetylsalicylic acid and 0.0200–0.1000 mg/mL for clopidogrel bisulfate, with a correlation coefficient (R² value) of 0.9999 for both active pharmaceutical ingredients (APIs). Accuracy was confirmed by calculated recoveries for acetylsalicylic acid (98.6–101.0%) and clopidogrel bisulfate (100.0–101.6%). The intra-day and the inter-day precision-calculated relative standard deviations are less than 1%, which indicates high precision of the method. The limits of detection and quantification for acetylsalicylic acid were 0.0004 and 0.0012 mg/mL, and for clopidogrel bisulfate 0.0002 mg/mL and 0.0007 mg/mL, respectively. Small variations in chromatographic conditions did not significantly affect qualitative and quantitative system responses, which proved robustness of method. The proposed RP-HPLC method was applied for simultaneous determination of clopidogrel bisulfate and acetylsalicylic acid from solid dispersions.

There is a growing demand for organic and natural cosmetic products, especially in the EU countries and the rest of the world, as the consumer awareness for the preservation of the environment and natural resources has increased, but above all with the belief that these products are safe. All cosmetic products, even organic and natural, that are placed on the market of EU countries must comply with the Cosmetics Regulation 1223/2009 EC requirements in terms of quality, safety and efficacy. However, there is no harmonized European regulation today, that sets out the criteria for natural and organic cosmetic products. The most important standards for natural and organic cosmetics in the EU countries are COSMOS and NATRUE standard. According to the requirements of these standards, selected raw materials, mainly of plant origin, which are processed by approved procedures, are allowed for organic and natural cosmetic products manufacturing. Numerous studies indicate that toxicological properties of natural substances deserve much more attention, in order to determine their safety. The safety, efficacy and quality of cosmetic products are prerequisites. That is why it is necessary to create a regulatory framework for natural and organic cosmetic products, which will not mislead the consumers and which will be more binding for manufacturers. Also, it is necessary to create a precise guideline for the safety assessment of organic and natural cosmetic products.